Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma (TACEforHCC)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, China
Guangdong General Hospital
The 458 Hospital of Chinese PLA
Kaiping Central Hospital
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00493402
First received: June 27, 2007
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).


Condition Intervention Phase
Hepatocellular Carcinoma
Procedure: Transarterial chemoembolization (TACE)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 365
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: combined chemotherapy with embolization
chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, with particle embolization.
Procedure: Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.
Experimental: combined chemotherapy without embolization
chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, without particle embolization.
Procedure: Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.
Experimental: single agent chemotherapy with embolization
chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
Procedure: Transarterial chemoembolization (TACE)
Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.

Detailed Description:

Transarterial chemoembolization (TACE) has been recommended as first line non-curative therapy for non-surgical patients with large/multifocal HCC who do not have vascular invasion or extrahepatic spread. There has not been any standardized protocol in the choice of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of embolization, and whether the chemotherapeutic agent should be given together, or before the embolizing agent.

Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (PRO) of different regimens of TACE.

Regimen 1: lipiodol combined chemotherapy with embolization

Regimen 2: lipiodol combined chemotherapy without embolization

Regimen 3: lipiodol single agent chemotherapy with embolization

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with minimal height of 150cm and minimal weight of 50 KG
  • Histological confirmed HCC
  • with no previous treatment
  • With unresectable tumor
  • With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm.
  • No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
  • No significant renal impairment (creatinine clearance < 30 mL/minute)
  • The following laboratory parameters:

    • Platelet count ≥ 60,000/µL
    • Hemoglobin ≥ 8.5 g/dL
    • Total bilirubin ≤ 1.5 mg/dL
    • ASL and AST ≤ 5 x upper limit of normal
    • Serum albumin ≥ 35 g/L
    • Serum creatinine ≤ 1.5 x upper limit of normal
    • INR ≤ 1.5 or a Pt/PTT within normal limits
    • Absolute neutrophil count (ANC) > 1,500/mm3
  • Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

  • Avascular tumor
  • Main portal vein obstruction without cavernous transformation
  • Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy
  • Obstructive jaundice
  • Severe underlying cardiac or renal diseases
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Pregnant or breast-feeding patients.
  • History of organ allograft
  • Active clinically serious infections
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493402

Locations
China, Guangdong
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Ministry of Health, China
Guangdong General Hospital
The 458 Hospital of Chinese PLA
Kaiping Central Hospital
Investigators
Principal Investigator: Jin-Qing Li, M.D. Cancer Center, Sun Yat-set University
  More Information

Publications:
Bruix J, Sherman M. Management of hepatocellular carcinoma. Hepatology 2005; 42:1208-1236.
Lau WY, Yu SC, Lai EC, Leung TW. Transarterial chemoembolization for hepatocellular carcinoma. J Am Coll Surg 2006; 202:155-168.
Ramsey DE, Kernagis LY, Soulen MC, Geschwind JF. Chemoembolization of hepatocellular carcinoma. J Vasc Interv Radiol 2002; 13:S211-221.

Responsible Party: Shi Ming, Dr., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00493402     History of Changes
Other Study ID Numbers: hcc-001
Study First Received: June 27, 2007
Last Updated: December 12, 2012
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
Antineoplastic Agents
administration & dosage
Carcinoma, Hepatocellular
Chemoembolization, Therapeutic
Humans
Liver Neoplasms
therapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 18, 2014